Phase 3 Study to Compare the Efficacy and Safety of Gemigliptin and Vildagliptin as Add-on Therapy to Metformin in People With Type 2 Diabetes Inadequately Controlled With Metformin

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: vildagliptin; Drug: GEMIGLIPTIN LS15-0444; Drug: metformin

• Registration Number: NCT02343926
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To compare the clinical efficacy of gemigliptin and vildagliptin as add-on therapy to metformin in terms of change in Hemoglobin A1c (HbA1c) reduction.

Secondary Objectives:

To compare the safety and tolerability of gemigliptin and vildagliptin:

* Number of patients who experience at least one episode of hypoglycemia.

* Number of patients experiencing adverse event (AE), serious adverse event (SAE).

* Assessment of patients compliance defined as number tablets returned by patients.

Detailed Description

The study consists of 2 weeks screening and 24 weeks of treatment (a total of 26 weeks).

The protocol includes a screening period of two weeks, after which they will be randomized to receive gemigliptin or vildagliptin.

Patients will be evaluated through 4 mandatory visits during the study. Visit 1: Week -2 (screening) Visit 2: Week 0 (randomization) Visit 3: Week 12 (efficacy and safety evaluation) Visit 4: Week 24 (efficacy and safety evaluation)

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-16
• Study First Submitted QC: 2015-01-16
• Study First Posted: 2015-01-22
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 443

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vildagliptin	vildagliptin	Vildagliptin administered twice a day for 24 weeks as add-on therapy to metformin
Gemigliptin	GEMIGLIPTIN LS15-0444	GEMIGLIPTIN LS15-0444 administered once a day for 24 weeks as add-on therapy to metformin
Gemigliptin	metformin	GEMIGLIPTIN LS15-0444 administered once a day for 24 weeks as add-on therapy to metformin
Vildagliptin	metformin	Vildagliptin administered twice a day for 24 weeks as add-on therapy to metformin

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c	Up to Week 24

Secondary Outcome Measures

Name	Time	Method
Change from baseline in postprandial glucose	Up to Week 24
Number of episode of hypoglycemia (symptomatic, asymptomatic, severe hypoglycemia)	Up to Week 24
Change from baseline in fasting plasma glucose	Up to Week 24
Percentage of patients achieving HbA1c <7% and <6.5%	Up to Week 24
Change from baseline in body weight	Up to Week 24
Number of adverse events	Up to Week 24
Number of serious adverse events	Up to Week 24
Percentage of patients with at least one episode of hypoglycemia	Up to Week 24

Trial Locations

Locations (1)

Investigational Site 03; 🇷🇺 Vladimir, Vladimirskaya Oblast, Russian Federation